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Genetic toxicity: in vitro

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in vitro gene mutation study in bacteria
Type of genotoxicity: gene mutation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
equivalent or similar to guideline
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
Type of assay:
bacterial forward mutation assay

Test material

Constituent 1
Reference substance name:
Fatty acids, coco, 2-sulfoethyl esters, sodium salts
EC Number:
EC Name:
Fatty acids, coco, 2-sulfoethyl esters, sodium salts
Cas Number:
Molecular formula:
Fatty acids, coco, 2-sulfoethyl esters, sodium salts
Details on test material:
- Name of test material: sodium cocoyl isethionate (LB7819-1)
- Physical state: white waxy flakes
- Analytical purity: 72.45%
- Lot/batch No.: 1247
- Storage condition of test material: Stored at room temperature.
Test substance characterised and test solution concentrations verified by sponsor.
Aqueous SCI suspensions/solutions of 1.0, 14.0 and 36.0% were found to be stable over eight day period.


Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
Post mitochondrial supernatant (S9) prepared from livers of male Sprague Dawley rats induced with single ip injection of Arochlor 1254 at 500mg/kg.
Test concentrations with justification for top dose:
1.0, 3.3, 10, 33, 100 µg (+s9 mix)
10, 33, 100, 333, 1000 µg (-S9 mix)
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: water
Negative solvent / vehicle controls:
Positive controls:
Positive control substance:
Migrated to IUCLID6: 2- aminoanthracene, sodium azide
Details on test system and experimental conditions:
METHOD OF APPLICATION: in medium; in agar (plate incorporation); preincubation; in suspension; as impregnation on paper disk

- Preincubation period: 20±2 minutes
- Exposure duration: 48 hours
Plates that were not counted immediately following the incubation period were stored at 4±2¿C until colony counting could be conducted.

SELECTION AGENT (mutation assays): Number of revertants

NUMBER OF REPLICATIONS: Each treatment was plated in triplicate.
Three independent experiments were conducted

NUMBER OF CELLS EVALUATED: 1.9 x 108 cells seeded per plate

Results and discussion

Test results
Key result
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
Positive controls validity:

Any other information on results incl. tables

In experiment B1, no positive responses were observed in any of the tester strains in the presence or absence of metabolic activation.  As toxicity was only marginal at the highest dose without metabolic activation, the top dose was adjusted to 333 µg/plate for the subsequent confirmatory assays

In experiment B2, no positive responses were observed with tester strains TA98, TA1535 and TA1538.  Tester strains TA100 and TA1537 were not reported due to unacceptable titre values and were retested in experiment B3.

In experiment B3, no positive reactions were observed in TA100 and TA1537 in the presence or absence of metabolic activation.  A 2 fold non-dose responsive increase was observed with tester strain TA1537 in the absence of metabolic activation, however, it was considered that increases of this magnitude (less than 3 fold) with this strain and non-dose-responsive increases are not evaluated as positive.

Applicant's summary and conclusion

Interpretation of results: Negative

The results of the assay, indicate that under the conditions of the study, the test article LB-7819-1 did not cause a positive response with any of the tester strains in the presence or absence of metabolic activation